Assistant Manager /Sr. Executive -Quality Assurance (CSV)

Roles and Responsibilities:

1. Responsible for monitoring of basic norms of cGMP, data integrity, GDP, safety & to maintain his personal health and hygiene.

2. QMS tool shall be initiated in case of any deviation or incidence, gaps in procedure or error observed and same will be reported to concern department head and QA.

3. To participate in review, execution & implementation for miscellaneous or addendum based protocol activity against regulatory audit compliance or recommended via QMS Tool activity, Server installation, restoration activity of data executed, approval of Backup, review and approval of the inventory list maintained by IT department, User Management activity & Access Privileges allocated by IT on respective systemat Vs International Site along with IT Department personneland to impart protocol base training as and when required against the activity to be performed by User or subject matter expert wherever applicable.

4. To participate in execution and review for Computer system validation carried out by IT department personnel with CFT (Cross Functional Team) & third party vendor/OEM (If any).

5. To perform and review the risk assessment activity required against the system, recommended action, QMS Tool generated activity located at Vs International Site.

6. Responsible for review of qualification activities of Equipment, Utility, Instruments, Water system, software base application system used & installed at Vs International.

7. To prepare, review, storage and effective implementation of site master file, validation master plan, all qualification related documents (URS/DQ/FAT/SAT/IQ/OQ/PQ) & calibration and preventive maintenance schedule for critical equipment/instruments.

8. Responsible for preparation, review & implementation of SOP related to QA and Cross Functional Team and their subsequent revision based on Regulatory requirement /periodic revision or any other requirement.

9. Responsible for preparation of the audit compliance report along with conducting self-inspection and approval of Outsourced agencies.

10. Responsible for activities related to vendor audit and qualification.

Preferred candidate profile

Candidate may refer above JD before applying and have Pharma OSD exposure.

Qualification -B. Pharm/ M.Sc./ M. Pharm

Experience -8 -12 Years

Location - Ready to relocate Daman location

Perks and benefits

As per Candidature

Interested Candidate may apply on :- gita.hr@vsinternational.co.in